Antiplatelet therapy in combination with rt-PA thrombolysis in ischemic stroke (ARTIS): rationale and design of a randomized controlled trial.

BACKGROUND: Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is currently the only approved acute therapy for ischemic stroke. After rt-PA-induced recanalization, reocclusion is observed in 20-34%, probably caused by platelet activation. In acute myocardial infarction, the combination of thrombolytic and antiplatelet therapy leads to a better outcome compared to thrombolytic treatment alone. In patients with acute ischemic stroke, several studies showed that those on antiplatelet treatment prior to rt-PA had an equal or even better outcome compared to patients without prior use of antiplatelet therapy, despite an increased risk of bleeding. METHODS: We present the protocol of a multicenter randomized clinical trial (n = 800) investigating the effects of immediate addition of aspirin to rt-PA on poor outcome (modified Rankin score >2) in ischemic stroke patients. CONCLUSION: This study will answer the question whether the combination of rt-PA and antiplatelet therapy improves the functional outcome in ischemic stroke patients.